The aim of the study is to assess the safety and immunogenicity of GlaxoSmithKline Biologicals' (formerly known as SmithKline Beecham Biologicals) combined diphtheria-tetanus-acellular pertussis vaccine in healthy adults, from the age of 18 onwards, in Australia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
550
Intramuscular, single dose
Intramuscular, single dose
Intramuscular, single dose
Occurrence of solicited local and general symptoms
Time frame: Within the 15-day (Day 0 - Day 14) follow-up period after the first injection
Immunogenicity with respect to components of the study vaccines
Time frame: One month after the first injection
Immunogenicity with respect to components of the study vaccines
Time frame: One month after the second injection
Occurrence of solicited local symptoms and fever
Time frame: Within the 15-day (Day 0 - Day 14) follow-up period after the second injection
Occurrence of general solicited symptoms to vaccination, other than fever
Time frame: Within the 15-day (Day 0 - Day 14) follow-up period after each vaccine administration
Occurrence of unsolicited symptoms
Time frame: Within 31 days (Day 0 - Day 30) after each vaccine administration
Occurrence of serious adverse experiences to vaccination
Time frame: Within 31 days (Day 0 - Day 30) after each vaccine administration
Immunogenicity with respect to components of the study vaccines
Time frame: Immediately prior to the booster vaccination
Immunogenicity with respect to components of the study vaccines
Time frame: One year after the vaccination in a subset of subjects from all the groups
Immunogenicity with respect to components of the study vaccines
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Time frame: 2, 3, 4 and 5 years after the vaccination